APPLICATION
ANDA077614
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-05
LATEST ACTION
2025-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARVEDILOLPrescription
CARVEDILOL 6.25MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 3.125MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 12.5MG · TABLET · ORAL
CARVEDILOLPrescription
CARVEDILOL 25MG · TABLET · ORAL
Approval history
2025-03-19Labeling · Supplement 27 · standardAP
2020-03-03Labeling · Supplement 17 · standardAP
2016-03-25Labeling · Supplement 15 · standardAP
2014-09-19Labeling · Supplement 9AP
2014-09-19Labeling · Supplement 6AP
2008-11-18Labeling · Supplement 3AP
2007-10-25Labeling · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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